Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma
Status:
Active, not recruiting
Trial end date:
2024-09-01
Target enrollment:
Participant gender:
Summary
Study is aimed at evaluating the activity of Trabectedin (arm A) in advanced leiomyosarcomas,
having Gemcitabine (arm B) as the comparator.
In addition to the randomized cohort, the study has also an observational prospective cohort
which include patients who will refuse the randomization or for whom the investigator will
not judge the randomization as an appropriate option.
In order to allow the participation of sites only to the prospective-observational (non
randomized) cohort, it was introduced the possibility to participate to the study and receive
the ethical approval only to the Observational Prospective Cohort In parallel an optional
translational study will be performed, in both cohorts, to identify factors predictive of the
activity of Trabectedin or Gemcitabine in this specific histotype.